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Efficacy and Safety Study of Advantan for Maintenance Treatment of Atopic Dermatitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00185510
First Posted: September 16, 2005
Last Update Posted: February 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  Purpose

Purpose of the study:

One bothering feature of atopic dermatitis is its relapsing nature. Hence, it is worthwhile to test modes how to efficiently prevent relapses or at least increase the time until the disease recurs. In order to give recommendations to other patients, this study is to scientifically describe efficacy and safety of a given regimen, namely a maintenance therapy with two days a week Advantan.


Condition Intervention Phase
Dermatitis, Atopic Drug: Methylprednisolone Aceponate (Advantan, BAY86-4862) Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-Blind, Placebo Controlled, Randomized, Multicenter, Parallel-Group Study to Compare the Efficacy and Safety of Advantan Cream Twice Weekly With Advabase Cream During a Maintenance Phase of 16 Weeks After Successful Treatment of Atopic Dermatitis With Advantan Cream

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Time to relapse in the maintenance phase (MP) [ Time Frame: Week 16 ]

Secondary Outcome Measures:
  • Patients' number of relapses in the maintenance phase [ Time Frame: Week 16 ]
  • Treatment success as assessed by Investigator Global Assessment (IGA) score [ Time Frame: Week 16 ]
  • Percentage change during Acute Phase (AP) and MP assessed by Modified Eczema Area and Severity Index (mEASI) [ Time Frame: Week 16 ]
  • Index lesion monitoring [ Time Frame: Week 16 ]
  • Change of disease during AP and MP as assessed by Patient Global Assessment [ Time Frame: Week 16 ]
  • Visual assessment of signs of atrophy [ Time Frame: Week 16 ]
  • Ultrasound for measurement of skin thickness in selected sites [ Time Frame: Up to week 16 ]
  • Dermatology Life Quality Index (CDLQI, DLQI) [ Time Frame: Week 16 ]
  • Adverse Event Collection [ Time Frame: Week 16 ]

Enrollment: 250
Study Start Date: March 2005
Study Completion Date: June 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Methylprednisolone Aceponate (Advantan, BAY86-4862)
In maintenance phase, Methylprednisolone Aceponate cream is applied topically twice a week.
Placebo Comparator: Arm 2 Drug: Placebo
2 days a week Vehicle (Advabase)

Detailed Description:

The study has initially been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Intendis GmbH, a Bayer HealthCare company, is the sponsor of the trial.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute 'Severe' or 'Very Severe' flare of atopic dermatitis; no minimum affected body surface
  • History of moderate to severe form of atopic dermatitis for at least two years

Exclusion Criteria:

  • Pregnancy, breast feeding
  • Known immune, hepatic, or renal insufficiency
  • Acute herpes simplex or mollusca contagiosa infection
  • Acute and severe impetigo contagiosa. A slight superinfection of eczema is no exclusion criterion
  • Severe other viral, bacterial, or fungal skin infection (chicken pox, prominent tinea corporis)
  • Acute infestations (e.g. head lice, scabies)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00185510


Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00185510     History of Changes
Other Study ID Numbers: 91424
2004-002673-22 ( EudraCT Number )
309189 ( Other Identifier: Company internal )
First Submitted: September 15, 2005
First Posted: September 16, 2005
Last Update Posted: February 25, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone aceponate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal